Closed Loop Control System Interface and Methods

ABSTRACT

Method and apparatus including calling, retrieving and/or initiating a programmed function in conjunction with execution of one or more commands related to a closed loop control algorithm, receiving one or more data in response to the one or more commands over a data interface, and executing the one or more commands related to the closed loop control algorithm based on the received one or more data are provided.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 12/503,022 filed Jul. 14, 2009, now U.S. Pat. No. 8,876,755,which claims priority under § 35 U.S.C. 119(e) to U.S. provisionalapplication No. 61/080,677 filed Jul. 14, 2008 entitled “Closed LoopControl System Interface and Methods”, the disclosures of each of whichare incorporated by reference for all purposes.

BACKGROUND

Commercial devices and systems for monitoring glucose levels in apatient are currently available. For example, FreeStyle Navigator®Continuous Glucose Monitoring System available from Abbott Diabetes CareInc., provides diabetes management tools for monitoring glucose levelsof a patient over an extended time period using a subcutaneous analytesensor, for example, in contact with interstitial fluid of the patient.Such devices and systems provide real time glucose information to thepatient to assist in improving glycemic control. Also available areinfusion devices such as external insulin pumps which are programmableto deliver insulin based on a programmed delivery profile to diabeticpatients, for example. Typically, such pumps are programmed to deliver apredetermined basal delivery profile, and periodically administer userspecified bolus dosage or temporary basal delivery.

In recent years, developments have been on going in closed loop therapysystems which automate the control of the insulin delivery based on realtime feedback of the patient's glucose levels. There are known closedloop control algorithms that are intended to model artificial pancreasto provide a fully automated and integrated system of glucose monitoringand insulin delivery.

With the development of different algorithms for closed loop control aswell as glucose monitoring systems and infusion devices, integration ofsuch components to provide compatibility has become a challenge.

SUMMARY

In view of the foregoing, a closed loop system interface device andmethods are provided in accordance with various embodiments of thepresent disclosure which provide compatibility with any developingclosed loop algorithm, and integration with the analyte monitoringsystem.

In one aspect, method and apparatus for calling a programmed function inconjunction with execution of one or more commands related to a closedloop control algorithm, receiving one or more data in response to theone or more commands over a data interface, and executing the one ormore commands related to the closed loop control algorithm based on thereceived one or more data are provided.

These and other objects, features and advantages of the presentdisclosure will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an integrated infusion device and analyte monitoringsystem in accordance with one embodiment of the present disclosure;

FIG. 2 illustrates an integrated infusion device and analyte monitoringsystem in accordance with another embodiment of the present disclosure;

FIG. 3 illustrates an integrated infusion device and analyte monitoringsystem in accordance with yet another embodiment of the presentdisclosure;

FIG. 4 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still another embodiment of the presentdisclosure;

FIG. 5 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still a further embodiment of the presentdisclosure;

FIG. 6 illustrates an integrated infusion device and monitoring systemin accordance with yet still a further embodiment of the presentdisclosure;

FIG. 7A illustrates an integrated infusion device and analyte monitoringsystem with the infusion device and the monitoring system transmitterintegrated into a single patch worn by the patient in accordance withone embodiment of the present disclosure and FIG. 7B illustrates a topview of the patch of FIG. 7A;

FIG. 8 illustrates a closed loop system interface for practicing one ormore embodiments of the present disclosure;

FIG. 9 illustrates an architecture for providing interface to integratethe components of the closed loop system in one aspect; and

FIG. 10 illustrates an architecture for providing interface to integratethe components of the closed loop system in another aspect.

DETAILED DESCRIPTION

FIG. 1 illustrates an integrated infusion device and analyte monitoringsystem in accordance with one embodiment of the present disclosure.Referring to FIG. 1, the integrated infusion device and analytemonitoring system 100 in one embodiment of the present disclosureincludes an infusion device 110 connected to an infusion tubing 130 forliquid transport or infusion, and which is further coupled to a cannula170. As can be seen from FIG. 1, the cannula 170 is configured to bemountably coupled to a transmitter unit 150, where the transmitter unit150 is also mountably coupled to an analyte sensor 160. Also provided isan analyte monitor unit 120 which is configured to wirelesslycommunicate with the transmitter unit 150 over a communication path 140.

Referring to FIG. 1, in one embodiment of the present disclosure, thetransmitter unit 150 is configured for unidirectional wirelesscommunication over the communication path 140 to the analyte monitorunit 120. In one embodiment, the analyte monitor unit 120 may beconfigured to include a transceiver unit (not shown) for bidirectionalcommunication over the communication path 140. The transmitter unit 150in one embodiment may be configured to periodically and/orintermittently transmit signals associated with analyte levels detectedby the analyte sensor 160 to the analyte monitor unit 120. The analytemonitor unit 120 may be configured to receive the signals from thetransmitter unit 150 and in one embodiment, is configured to performdata storage and processing based on one or more preprogrammed orpredetermined processes.

For example, in one embodiment, the analyte monitor unit 120 isconfigured to store the received signals associated with analyte levelsin a data storage unit (not shown). Alternatively, or in addition, theanalyte monitor unit 120 may be configured to process the signalsassociated with the analyte levels to generate trend indication by, forexample, visual display of a line chart or an angular icon based displayfor output display on its display unit 121. Additional information maybe output displayed on the display unit 121 of the analyte monitor unit120 including, but not limited to, the substantially contemporaneous andreal time analyte level of the patient received from the transmitterunit 150 as detected by the sensor 160. The real time analyte level maybe displayed in a numeric format or in any other suitable format whichprovides the patient with the accurate measurement of the substantiallyreal time analyte level detected by the sensor 160.

Additional analytes that may be monitored or determined by the sensor160 include, for example, acetyl choline, amylase, bilirubin,cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB),creatine, DNA, fructosamine, glucose, glutamine, growth hormones,hormones, ketones, lactate, peroxide, prostate-specific antigen,prothrombin, RNA, thyroid stimulating hormone, and troponin. Theconcentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined.

Referring back to FIG. 1, the sensor 160 may include a short term (forexample, 3 day, 5 day or 7 day use) analyte sensor which is replacedafter its intended useful life. Moreover, in one embodiment, the sensor160 is configured to be positioned subcutaneous to the skin of thepatient such that at least a portion of the analyte sensor is maintainedin fluid contact with the patient's analyte such as, for example,interstitial fluid or blood. In addition, the cannula 170, which isconfigured to similarly be positioned under the patient's skin, isconnected to the infusion tubing 130 of the infusion device 110 so as todeliver medication such as insulin to the patient. Moreover, in oneembodiment, the cannula 170 is configured to be replaced with thereplacement of the sensor 160.

In one aspect of the present disclosure, the cannula 170 and the sensor160 may be configured to be subcutaneously positioned under the skin ofthe patient using an insertion mechanism (not shown) such as aninsertion gun which may include, for example, a spring biased or loadedinsertion mechanism to substantially accurately position the cannula 170and the sensor 160 under the patient's skin. In this manner, the cannula170 and the sensor 160 may be subcutaneously positioned withsubstantially little or no perceived pain by the patient. Alternatively,the cannula 170 and/or the sensor 160 may be configured to be manuallyinserted by the patient through the patient's skin. After positioningthe cannula 170 and the sensor 160, they may be substantially firmlyretained in position by an adhesive layer 180 which is configured toadhere to the skin of the patient for the duration of the time periodduring which the sensor 160 and the cannula 170 are subcutaneouslypositioned.

Moreover, in one embodiment, the transmitter unit 150 may be mountedafter the subcutaneous positioning of the sensor 160 and the cannula 150so as to be in electrical contact with the sensor electrodes. Similarly,the infusion tubing 130 may be configured to operatively couple to thehousing of the transmitter unit 150 so as to be in accurately positionedfor alignment with the cannula 170 and to provide a substantially watertight seal. Additional detailed description of the analyte monitoringsystem including the sensor 160, transmitter unit 150 and the analytemonitor unit 120 is provided in U.S. Pat. No. 6,175,752, assigned to theassignee of the present disclosure, Abbott Diabetes Care Inc., thedisclosure of which is incorporated by reference for all purposes.

Referring back to FIG. 1, the infusion device 110 may includecapabilities to program basal profiles, calculation of bolus dosesincluding, but is not limited to, correction bolus, carbohydrate bolus,extended bolus, and dual bolus, which may be performed by the patientusing the infusion device 110, and may be based on one or more factorsincluding the patient's insulin sensitivity, insulin on board, intendedcarbohydrate intake (for example, for the carbohydrate bolus calculationprior to a meal), the patient's measured or detected glucose level, andthe patient's glucose trend information. In a further embodiment, thebolus calculation capabilities may also be provided in the analytemonitor unit 120.

In one embodiment, the analyte monitor unit 120 is configured with asubstantially compact housing that can be easily carried by the patient.In addition, the infusion device 110 similarly may be configured as asubstantially compact device which can be easily and conveniently wornon the patient's clothing (for example, housed in a holster or acarrying device worn or clipped to the patient's belt or other parts ofthe clothing). Referring yet again to FIG. 1, the analyte monitor unit120 and/or the infusion device 110 may include a user interface such asinformation input mechanism 112, 122 by the patient as well as dataoutput including, for example, the display unit 121 on the analytemonitor unit 120, or similarly a display unit 111 on the infusion device110.

One or more audio output devices such as, for example, speakers orbuzzers may be integrated with the housing of the infusion device 110and/or the analyte monitor unit 120 so as to output audible alerts oralarms based on the occurrence of one or more predetermined conditionsassociated with the infusion device 110 or the analyte monitor unit 120.For example, the infusion device 110 may be configured to output anaudible alarm or alert to the patient upon detection of an occlusion inthe infusion tubing 130 or the occurrence of a timed event such as areminder to prime the infusion tubing upon replacement of the cannula170, and the like. The analyte monitor unit 120 may similarly beconfigured to output an audible alarm or alert when a predeterminedcondition or a pre-programmed event occurs, such as, for example, areminder to replace the sensor 160 after its useful life (of 3 days, 5days or 7 days), or one or more alerts associated with the data receivedfrom the transmitter unit 150 corresponding to the patient's monitoredanalyte levels. Such alerts or alarms may include a warning alert to thepatient that the detected analyte level is beyond a predeterminedthreshold level, or the trend of the detected analyte levels within agiven time period is indicative of a significant condition such aspotential hyperglycemia or hypoglycemia, which require attention orcorrective action. It is to be noted that the examples of audible alarmsand/or alerts are described above for illustrative purposes only, thatwithin the scope of the present disclosure, other events or conditionsmay be programmed into the infusion device 110 or the analyte monitorunit 120 or both, so as to alert or notify the patient of the occurrenceor the potential occurrence of such events or conditions.

In addition, within the scope of the present disclosure, audible alarmsmay be output alone, or in combination with one or more of a visualalert such as an output display on the display unit 111, 121 of theinfusion device 110 or the analyte monitor unit 120, respectively, orvibratory alert which would provide a tactile indication to the patientof the associated alarm and/or alert.

Moreover, referring yet again to FIG. 1, while one analyte monitor unit120 and one transmitter unit 150 are shown, within the scope of thepresent disclosure, additional analyte monitor units or transmitterunits may be provided such that, for example, the transmitter unit 150may be configured to transmit to multiple analyte monitor unitssubstantially simultaneously. Alternatively, multiple transmitter unitscoupled to multiple sensors concurrently in fluid contact with thepatient's analyte may be configured to transmit to the analyte monitorunit 120, or to multiple analyte monitor units. For example, anadditional transmitter unit coupled to an additional sensor may beprovided in the integrated infusion device and analyte monitoring system100 which does not include the cannula 170, and which may be used toperform functions associated with the sensor 160 such as sensorcalibration, sensor data verification, and the like.

In one embodiment, the transmitter unit 150 is configured to transmitthe sampled data signals received from the sensor 160 withoutacknowledgement from the analyte monitor unit 120 that the transmittedsampled data signals have been received. For example, the transmitterunit 150 may be configured to transmit the encoded sampled data signalsat a fixed rate (e.g., at one minute intervals) after the completion ofthe initial power on procedure. Likewise, the analyte monitor unit 120may be configured to detect such transmitted encoded sampled datasignals at predetermined time intervals. Alternatively, the transmitterunit 150 and the analyte monitor unit 120 may be configured forbi-directional communication over the communication path 140.

Additionally, in one aspect, the analyte monitor unit 120 may includetwo sections. The first section of the analyte monitor unit 120 mayinclude an analog interface section that is configured to communicatewith the transmitter unit 150 via the communication path 140. In oneembodiment, the analog interface section may include an RF receiver andan antenna for receiving and amplifying the data signals from thetransmitter unit 150, which are thereafter, demodulated with a localoscillator and filtered through a band-pass filter. The second sectionof the analyte monitor unit 120 may include a data processing sectionwhich is configured to process the data signals received from thetransmitter unit 150 such as by performing data decoding, errordetection and correction, data clock generation, and data bit recovery,for example.

In operation, upon completing the power-on procedure, the analytemonitor unit 120 is configured to detect the presence of the transmitterunit 150 within its range based on, for example, the strength of thedetected data signals received from the transmitter unit 150 or apredetermined transmitter identification information. Upon successfulsynchronization with the transmitter unit 150, the analyte monitor unit120 is configured to begin receiving from the transmitter unit 150 datasignals corresponding to the patient's detected analyte, for exampleglucose, levels.

Referring again to FIG. 1, the analyte monitor unit 120 or the infusiondevice 110, or both may be configured to further communicate with a dataprocessing terminal (not shown) which may include a desktop computerterminal, a data communication enabled kiosk, a laptop computer, ahandheld computing device such as a personal digital assistant (PDAs),or a data communication enabled mobile telephone, and the like, each ofwhich may be configured for data communication via a wired or a wirelessconnection. The data processing terminal for example may includephysician's terminal and/or a bedside terminal in a hospitalenvironment, for example.

The communication path 140 for data communication between thetransmitter unit 150 and the analyte monitor unit 120 of FIG. 1 mayinclude an RF communication link, Bluetooth® communication link,infrared communication link, or any other type of suitable wirelesscommunication connection between two or more electronic devices. Thedata communication link may also include a wired cable connection suchas, for example, but not limited to, an RS232 connection, USBconnection, or serial cable connection.

Referring yet again to FIG. 1, in a further aspect of the presentdisclosure, the analyte monitor unit 120 or the infusion device 110 (orboth) may also include a test strip port configured to receive a bloodglucose test strip for discrete sampling of the patient's blood forglucose level determination. An example of the functionality of bloodglucose test strip meter unit may be found in Freestyle® Blood GlucoseMeter available from the assignee of the present disclosure, AbbottDiabetes Care Inc.

In the manner described above, in one embodiment of the presentdisclosure, the cannula 170 for infusing insulin or other suitablemedication is integrated with the adhesive patch 180 for the sensor 160and the transmitter unit 150 of the analyte monitoring system.Accordingly, only one on-skin patch can be worn by the patient (forexample, on the skin of the abdomen) rather than two separate patchesfor the infusion device cannula 170, and the analyte monitoring systemsensor 160 (with the transmitter unit 150). Thus, the Type-1 diabeticpatient may conveniently implement infusion therapy in conjunction withreal time glucose monitoring while minimizing potential skin irritationon the adhesive patch 180 site on the patient's skin, and thus providemore insertion sites with less irritation.

In addition, the integrated infusion device and analyte monitoringsystem 100 as shown in FIG. 1 may be configured such that the infusiontubing 130 may be disconnected from the infusion device 110 as well asfrom the housing of the transmitter unit 150 (or the adhesive patch 180)such that, optionally, the patient may configure the system ascontinuous analyte monitoring system while disabling the infusion device110 functionality.

Moreover, in accordance with one embodiment of the present disclosure,the patient may better manage the physiological conditions associatedwith diabetes by having substantially continuous real time glucose data,trend information based on the substantially continuous real timeglucose data, and accordingly, modify or adjust the infusion levelsdelivered by the infusion device 110 from the pre-programmed basalprofiles that the infusion device 110 is configured to implement.

FIG. 2 illustrates an integrated infusion device and analyte monitoringsystem in accordance with another embodiment of the present disclosure.Referring to FIG. 2, the integrated infusion device and analytemonitoring system 200 in one embodiment of the present disclosureincludes an integrated infusion device and analyte monitor unit 210which is coupled to an infusion tubing 220 connected to the cannula 260.Also shown in FIG. 2 is a transmitter unit 240 which is in electricalcontact with an analyte sensor 250, where the cannula 260 and theanalyte sensor 250 are subcutaneously positioned under the skin of thepatient, and retained in position by an adhesive layer or patch 270.

Referring to FIG. 2, the integrated infusion device and analyte monitorunit 210 is configured to wirelessly communicate with the transmitterunit 240 over a communication path 230 such as an RF communication link.Compared with the embodiment shown in FIG. 1, it can be seen that in theembodiment shown in FIG. 2, the infusion device and the analyte monitorare integrated into a single housing 210. In this manner, thetransmitter unit 240 may be configured to transmit signals correspondingto the detected analyte levels received from the analyte sensor 250 tothe integrated infusion device and analyte monitor unit 210 for dataanalysis and processing.

Accordingly, the patient may conveniently receive real time glucoselevels from the transmitter unit 240 and accordingly, determine whetherto modify the existing basal profile(s) in accordance with which insulinis delivered to the patient. In this manner, the functionalities of theanalyte monitor unit may be integrated within the compact housing of theinfusion device to provide additional convenience to the patient by, forexample, providing the real time glucose data as well as other relevantinformation such as glucose trend data to the user interface of theinfusion device, so that the patient may readily and easily determineany suitable modification to the infusion rate of the insulin pump.

In one embodiment, the configurations of each component shown in FIG. 2including the cannula 260, the analyte sensor 250, the transmitter unit240, the adhesive layer 270, the communication path 230, as well as theinfusion tubing 220 and the functionalities of the infusion device andthe analyte monitor are substantially similar to the correspondingrespective component as described above in conjunction with FIG. 1.

Accordingly, in one embodiment of the present disclosure, the additionalconvenience may be provided to the patient in maintaining and enhancingdiabetes management by, for example, having a single integrated devicesuch as the integrated infusion device and analyte monitor unit 210which would allow the patient to easily manipulate and manage insulintherapy using a single user interface system of the integrated infusiondevice and analyte monitor unit 210. Indeed, by providing many of theinformation associated with the glucose levels and insulin infusioninformation in one device, the patient may be provided with theadditional convenience in managing diabetes and improving insulintherapy.

FIG. 3 illustrates an integrated infusion device and analyte monitoringsystem in accordance with yet another embodiment of the presentdisclosure. Referring to FIG. 3, the integrated infusion device andanalyte monitoring system 300 in one embodiment of the presentdisclosure includes an infusion device 310 connected to an infusiontubing 340 coupled to a cannula 370. The cannula 370 is configured to bepositioned subcutaneously under the patient's skin and substantiallyretained in position by an adhesive layer 380. Also retained inposition, as discussed above and similar to the embodiments described inconjunction with FIGS. 1-2, is an analyte sensor 360 also positionedsubcutaneously under the patient's skin and maintained in fluid contactwith the patient's analyte. A transmitter unit 350 is provided so as tobe electrically coupled to the analyte sensor 360 electrodes. Also, ascan be seen from FIG. 3, in one embodiment, the infusion tubing 340 isconnected to the housing of the transmitter unit 350 so as to connect tothe cannula 370 disposed under the patient's skin.

Referring to FIG. 3, also provided is an analyte monitoring unit 320configured to wirelessly communicate with the transmitter unit 350 toreceive data therefrom associated with the analyte levels of the patientdetected by the analyte sensor 360. Referring to FIG. 3, in oneembodiment, the infusion device 310 does not include a user interfacesuch as a display unit and/or an input unit such as buttons or a jogdial. Instead, the user interface and control mechanism is provided onthe analyte monitoring unit 320 such that the analyte monitoring unit320 is configured to wirelessly control the operation of the infusiondevice 310 and further, to suitably program the infusion device 310 toexecute pre-programmed basal profile(s), and to otherwise control thefunctionality of the infusion device 310.

More specifically, all of the programming and control mechanism for theinfusion device 310 is provided in the analyte monitoring unit 320 suchthat when the patient is wearing the infusion device 310, it may be worndiscreetly under clothing near the infusion site on the patient's skin(such as abdomen), while still providing convenient access to thepatient for controlling the infusion device 310 through the analytemonitoring unit 320.

In addition, in one embodiment, the configurations of each componentshown in FIG. 3 including the cannula 370, the analyte sensor 360, thetransmitter unit 350, the adhesive layer 380, the communication path330, as well as the infusion tubing 340 and the functionalities of theinfusion device and the analyte monitoring unit 320 are substantiallysimilar to the corresponding respective component as described above inconjunction with FIG. 1. However, the infusion device 310 in theembodiment shown in FIG. 3 is configured with a transceiver or anequivalent communication mechanism to communicate with the analytemonitoring unit 320.

In this manner, in one embodiment of the present disclosure,configuration of the infusion device 310 without a user interfaceprovides a smaller and lighter housing and configuration for theinfusion device 310 which would enhance the comfort in wearing and/orcarrying the infusion device 310 with the patient. Moreover, since thecontrol and programming functions of the infusion device 310 is providedon the analyte monitoring unit 320, the patient may conveniently programand/or control the functions and operations of the infusion device 310without being tethered to the infusion tubing 340 attached to thecannula 370 which is positioned under the patient's skin. In addition,since the programming and control of the infusion device 310 is remotelyperformed on the analyte monitoring unit 320, the infusion tubing 340may be shorter and thus less cumbersome.

FIG. 4 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still another embodiment of the presentdisclosure. Referring to FIG. 4, the integrated infusion device andanalyte monitoring system 400 in one embodiment of the presentdisclosure includes an infusion device 410 configured to wirelesslycommunicate with an analyte monitoring unit 420 over a communicationpath 430 such as an RF (radio frequency) link. In addition, as can befurther seen from FIG. 4, the infusion device 410 is connected to aninfusion tubing 440 which has provided therein integral wires connectedto the analyte sensor electrodes. As discussed in further detail below,the measured analyte levels of the patient is received by the infusiondevice 410 via the infusion tubing 440 and transmitted to the analytemonitoring unit 420 for further processing and analysis.

More specifically, referring to FIG. 4, the integrated infusion deviceand analyte monitoring system 400 includes a patch 450 provided with acannula 470 and an analyte sensor 460. The cannula 470 is configured todeliver or infuse medication such as insulin from the infusion device410 to the patient. That is, in one embodiment, the cannula 470 and theanalyte sensor 460 are configured to be positioned subcutaneous to thepatient's skin. The analyte sensor 460 is configured to be positioned influid contact with the patient's analyte.

In this manner, the analyte sensor 460 is electrically coupled tointegral wires provided within the infusion tubing 440 so as to providesignals corresponding to the measured or detected analyte levels of thepatient to the infusion device 410. In one embodiment, the infusiondevice 410 is configured to perform data analysis and storage, such thatthe infusion device 410 may be configured to display the real timemeasured glucose levels to the patient on display unit 411. In additionto or alternatively, the infusion device 410 is configured to wirelesslytransmit the received signals from the analyte sensor 460 to the analytemonitoring unit 420 for data analysis, display, and/or storage and theanalyte monitoring unit 420 may be configured to remotely control thefunctions and features of the infusion device 410 providing additionaluser convenience and discreteness.

Referring back to FIG. 4, in one embodiment, the patch 450 may beconfigured to be substantially small without a transmitter unit mountedthereon, and provided with a relatively small surface area to beattached to the patient's skin. In this manner, the patient may beprovided with added comfort in having a substantially compact housingmounted on the skin (attached with an adhesive layer, for example), toinfuse medication such as insulin, and for continuous analyte monitoringwith the analyte sensor 460.

FIG. 5 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still a further embodiment of the presentdisclosure. As compared with the embodiment shown in FIG. 4, theintegrated infusion device and analyte monitoring system 500 of FIG. 5includes an integrated infusion device and analyte monitoring unit 510.Accordingly, one user interface is provided to the user including thedisplay unit 511 and input buttons 512 provided on the housing of theintegrated infusion device and analyte monitoring unit 510. Also shownin FIG. 5 are infusion tubing 520 with integral wires disposed thereinand connected to an analyte sensor 540 with electrodes in fluid contactwith the patient's analyte. Moreover, as can be seen from FIG. 5, anadhesive patch 530 is provided to retain the subcutaneous position of acannula 550 and the analyte sensor 540 in the desired positions underthe patient's skin.

Optionally, the integrated infusion device and analyte monitoring unit510 may be provided with wireless or wired communication capability soto communicate with a remote terminal such as a physician's computerterminal over a wireless communication path such as RF communicationlink, or over a cable connection such as a USB connection, for example.Referring back to FIG. 5, in one embodiment of the present disclosure,the diabetic patient using an infusion therapy is provided with lesscomponents to handle or manipulate further simplifying insulin therapyand glucose level monitoring and management.

FIG. 6 illustrates an integrated infusion device and monitoring systemin accordance with yet still a further embodiment of the presentdisclosure. Referring to FIG. 6, the integrated infusion device andanalyte monitoring system 600 is provided with an infusion devicewithout a user interface, and configured to wirelessly communicate withan analyte monitoring unit 620 over a communication path 630 such as anRF link. The infusion device 610 which may be provided in a compacthousing since it does not incorporate the components associated with auser interface, is connected to an infusion tubing 640 having disposedtherein integral wires correspondingly connected to the electrodes ofanalyte sensor 660 in fluid contact with the patient's analyte. Inaddition, the compact adhesive patch 650 in one embodiment is configuredto retain cannula 670 and the analyte sensor 660 in the desired positionunder the skin of the patient.

Similar to the embodiment shown in FIG. 3, the analyte monitoring unit620 is configured to control and program the infusion device 610 overthe communication link 630. In this manner, the control and programmingfunctions of the infusion device 610 may be remotely performed by theanalyte monitoring unit 620, providing convenience to the patient.

FIG. 7A illustrates an integrated infusion device and analyte monitoringsystem with the infusion device and the monitoring system transmitterintegrated into a single patch worn by the patient in accordance withone embodiment of the present disclosure and FIG. 7B illustrates a topview of the patch of FIG. 7A. Referring to FIGS. 7A and 7B, theintegrated infusion device and analyte monitoring system 700 includes anintegrated patch pump and transmitter unit 710 provided on an adhesivelayer 760, and which is configured to be placed on the skin of thepatient, so as to securely position cannula 750 and analyte sensor 740subcutaneously under the skin of the patient. The housing of theintegrated infusion pump and transmitter unit 710 is configured in oneembodiment to include the infusion mechanism to deliver medication suchas insulin to the patient via the cannula 750.

In addition, the integrated patch pump and transmitter unit 710 isconfigured to transmit signals associated with the detected analytelevels measured by the analyte sensor 740, over a wireless communicationpath 730 such as an RF link. The signals are transmitted from the onbody integrated patch pump and transmitter unit 710 to a controller unit720 which is configured to control the operation of the integrated patchpump and transmitter unit 710, as well as to receive the transmittedsignals from the integrated patch pump and transmitter unit 710 whichcorrespond to the detected analyte levels of the patient.

Referring back to FIGS. 7A and 7B, in one embodiment, the infusionmechanism of the integrated patch pump and transmitter unit 710 mayinclude the infusion device of the type described in U.S. Pat. No.6,916,159 assigned to the assignee of the present disclosure, AbbottDiabetes Care Inc., the disclosure of which is incorporated by referencefor all purposes. In addition, while a wireless communication over thecommunication path 730 is shown in FIG. 7A, the wireless communicationpath 730 may be replaced by a set of wires to provide a wired connectionto the controller unit 720.

In this manner, in one embodiment of the present disclosure, theintegrated infusion device and analyte monitoring system 700 does notuse an infusion tubing which may provide additional comfort andconvenience to the patient by providing additional freedom from havingto wear a cumbersome tubing.

FIG. 8 illustrates a closed loop system interface for practicing one ormore embodiments of the present disclosure. Referring to the Figure, inone aspect, the closed loop architecture includes a PC terminal 810,such as a computer terminal which includes the predefined closed loopalgorithm, in communication with a controller 820 and a pump 830. Thecontroller 820 in one aspect is configured to receive analyte data overa data connection 860 such as an RF link, from a data transmitter 870which is connected to an analyte sensor 880. In one aspect, thecontroller 820 in combination with the transmitter 870 and the analytesensor 880 comprise the analyte monitoring system described above.

Referring again to FIG. 8, the pump 830 is connected to an infusionset/tubing 890 for delivering medication such as insulin to a user.While not shown, the analyte sensor 880 and the cannula of the infusionset/tubing is transcutaneously positioned under the skin layer of thepatient to monitor analyte levels and deliver medication, respectively.As can be seen, there are provided data interface 840, 850 between thecontroller 820 and PC terminal 810, and the pump 830 and the PC terminal810. In one aspect, the data interfaces 840, 850 include USB dataconnection for data transfer between the various components described.In a further aspect, the closed loop algorithm may be provided in thecontroller 820 in which case, the PC terminal 810 shown in FIG. 8 may bean optional device, and the data interface 840, 850 may be similarlyoptional. In such configuration, the controller 820 in one aspect may beconfigured to communicate with the pump 830 via data interface 895 whichmay include, for example, one or more of an RF (radio frequency)communication interface/link, a wired data interface such as a USB(universal serial bus) or serial data communication interface or anyother suitable data interface for bi-directional data communicationbetween the controller 820 and the pump 830.

As discussed in further detail below, in accordance with embodiments ofthe present disclosure, architecture to support integration of closedloop control algorithm (whether developed and resident in the PCterminal 810), or integrated into controller 820 are provided. That is,by providing application programming interface (API) to the componentsof the closed loop system, integration with different control algorithmfor implementation as well as testing may be easily achieved with datacompatibility and little or no modification to the closed loop controlalgorithm.

FIG. 9 illustrates an architecture for providing data/control interfaceto integrate the components of the closed loop control system in oneaspect. Referring to FIG. 9, as can be seen, there is provided transportlayers between the controller/pump and the PC terminal. That is, in oneembodiment, using the existing USB data ports, data communication may beachieved by serial communication with the PC terminal such that betweenthe devices, an interface layer such as a serializer is provided whichencapsulates, for example, the serial commands from the continuousglucose monitoring (CGM) controller to the closed loop algorithmresident in the PC terminal. In one aspect, the serializer may beconfigured to provide API to execute the necessary and/or desiredcommands for monitoring and updating the status of the commands.

Referring to FIG. 9, the closed loop algorithm resident in the PCterminal as shown may be configured to call or retrieve forexecution/implementation one or more desired functions based, forexample, on its internal clock or timer (or programmed orpre-programmed), and in response, triggers or initiates the CGM(continuous glucose monitoring) data processing to serialize theresponsive (based on the function call) data which is then provided tocorresponding deserializer on the PC terminal via the USB connection.For example, the function call may include a serial command requestingglucose data for the past 10 minutes. The closed loop algorithm mayexecute this function call to the controller, and in response thereto,the controller may be configured to retrieve the stored glucose datareceived from the CGM transmitter and provide that information to thedeserializer in the PC terminal as a data table, for example.

That is, in one aspect, the application programming interface (API)provided on the controller and the PC terminal are configured tocommunicate over the data connection (for example, the USB connection)based on serial commands, and thereafter, provided to the closed loopcontrol algorithm for appropriate processing related to control of oneor more of the pump parameters or the controller (continuous glucosemonitoring) parameters. More specifically, as shown in FIG. 9, thecommand interface resident in the PC terminal may be configured togenerate the appropriate or suitable serial command to implement thedesired closed loop control based on the data received from thecontroller, and thereafter, via the serializer provide the command tothe pump and/or the controller over the data connection, which, in oneaspect, are configured to deserialize the command for execution and/orimplementation.

In this manner, in one aspect, there is provided an interface modulewhich is configured to integrate the closed loop control algorithm withthe continuous glucose monitoring system and infusion device that do notrequire modification to the closed loop control algorithm to providecompatibility and functional integration. For example, in one aspect,serial commands in conjunction with application programming interface(API) are provided to integrate the closed loop system componentswithout changing the closed loop control algorithm. In one aspect,without modifying the interface communication or control, the patientmay alter or replace the existing closed loop control algorithm toanother algorithm that may be more suited to the patient.

Referring to FIG. 9, while the closed loop control algorithm is shown toreside in the PC terminal, within the scope of the present disclosure,the closed loop control algorithm may be provided in the controller,which, in turn, may be configured for data communication with the pumpas well as the sensor interface (transmitter) coupled to an analytesensor for analyte monitoring. That is, in a further aspect, the PCterminal may be provided as an optional data processing terminal and theclosed loop control algorithm may be implemented using the controllerdevice in conjunction with the analyte sensor interface and the pump.This embodiment is further described in detail below in conjunction withFIG. 10.

FIG. 10 illustrates an architecture for providing interface to integratethe components of the closed loop control system in another aspect. Asshown, in one aspect, the closed loop control algorithm is integrated inthe controller such that the use of the PC terminal with closed loopalgorithm may be optional, and the serial commands used may not benecessary. For example, with the application programming interface (API)provided to the controller and the pump, in one aspect, the closed loopcontrol algorithm may be executed based on the data received from thecontroller related to the real time monitored glucose levels, and inresponse thereto, provide or issue one or more function calls to commandor control the pump and/or the controller to implement the determinedcommand or control based on the executed closed loop control algorithm.As discussed, in accordance with the embodiments of the presentdisclosure, the defined APIs may be implemented with any closed loopcontrol algorithm and integrated with compatibility.

Within the scope of the present disclosure, other compatibleconfigurations are contemplated in conjunction with a closed loopcontrol system for insulin therapy and diagnosis which are compatiblewith a variety of closed loop control algorithms without specificmodifications to the control algorithms for implementation. In aspectsof the present disclosure, the function calls or commands executed orimplemented by the one or more APIs include data integrity verification,for example, by including a CRC (cyclic redundancy check) verificationsuch that it may be necessary to verify the checksum of the API commandbefore calling the associated function.

In a further aspect, the defined or programmable APIs may be associatedwith one or more functions related to the medication delivery profile(e.g., one or more basal delivery profiles, temporary basal profile,delivery rates, delivery duration), delivery profile modification(including, for example, conditions for start/stop of one or morepredetermined delivery profiles, conditions defining switching betweenmultiple delivery profiles), safety shut off routine, device (pumpand/or controller) operational status monitoring, data processing modesincluding, for example, batch mode, backup, upload, retrieval, timestamping, logging and the like. Moreover, other compatible APIs arecontemplated within the scope of the present disclosure to providecompatibility with multiple closed loop control algorithms and whichdoes not require modification to the algorithms in order to execute orcall associated functions or parameters.

In still a further aspect, the defined or programmable APIs may beassociated with one or more functions related to the analyte monitoringsuch as, but not limited to, frequency of analyte data logging, analytesensor based events such as sensor calibration schedule, modification tothe calibration schedule, diagnosis of sensor operation, failure modesrelated to the analyte sensor, or analyte sensor replacement schedules.In further aspects of the present disclosure, the defined orprogrammable APIs may be associated with one or more data processingfunctions from the analyte sensor interface and/or the pump, including,for example, time corresponding the medication delivery profile with themonitored analyte levels, determination or processing of the rate ofchange information of the monitored analyte levels in conjunction withthe medication delivery profile such as the basal profile, monitoring ofthe temperature (on-skin, body temperature, and the like), for example.In addition, alarm or alert conditions associated with the closed loopcontrol algorithm may be implemented using one or more of the defined orprogrammable APIs including, for example, but not limited to, occlusiondetection in the medication delivery path, rapid rise or decline in themonitored analyte levels, for example.

Accordingly, a method in one aspect includes initiating a programmedfunction in conjunction with execution of one or more commands relatedto a closed loop control algorithm, receiving one or more data inresponse to the one or more commands over a data interface, andexecuting the one or more commands related to the closed loop controlalgorithm based on the received one or more data.

The programmed function may be initiated based on an applicationprogramming interface function.

The closed loop control algorithm may include closed loop diabetesmanagement algorithm.

In one aspect, the closed loop control algorithm may be configured tomodify a delivery profile of a medication.

The closed loop control algorithm may be configured to request a bloodglucose value.

The one or more commands in one aspect may include one or more serialcommands, where the received one or more data over the interface may beserialized or formatted for serial communication.

The one or more commands may include a command to retrieve one or moreof the current or prior monitored analyte level, where the analyte levelmay include glucose level.

An apparatus in accordance with another embodiment includes a storageunit, and one or more processors coupled to the storage unit, the one ormore processors configured to initiate a programmed function inconjunction with execution of one or more commands related to a closedloop control algorithm, to receive one or more data in response to theone or more commands over a data interface; and to execute the one ormore commands related to the closed loop control algorithm based on thereceived one or more data.

A system in accordance with yet another embodiment includes a controlunit including a memory unit having stored therein a closed loop controlalgorithm for execution, and an insulin delivery device in signalcommunication with the control unit for executing one or more medicationdelivery functions based on one or more signals received from thecontrol unit, wherein the control unit may include a user interface forinitiating one or more application programming interface functionassociated with one or more of the operation of the insulin deliverydevice, and further wherein the insulin delivery device may beconfigured to execute the one or more functions associated with the oneor more of the initiated application programming interface functions.

The closed loop control algorithm stored in the memory device of thecontrol unit may include a plurality of closed loop control algorithms.

Various other modifications and alternations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments.

What is claimed is:
 1. An apparatus comprising: a control unitconfigured for communication with a medication delivery device throughat least a first application programming interface, the control unitincluding a memory unit having stored therein a plurality of closed loopcontrol algorithms associated with one or more operations of themedication delivery device, wherein the control unit is configured toretrieve a first closed loop control algorithm from the plurality ofstored closed loop control algorithms, and to retrieve at least a secondcontrol algorithm from the plurality of stored closed loop controlalgorithms and replace the first closed loop control algorithm with theat least second closed loop control algorithm, wherein the first closedloop control algorithm and the at least second closed loop controlalgorithm are compatible between the control unit and the medicationdelivery device through the at least first application programminginterface.
 2. The apparatus of claim 1, wherein the first closed loopcontrol algorithm and the at least second closed loop control algorithmare compatible with the medication delivery device through the at leastfirst application programming interface without the first closed loopcontrol algorithm or the at least second closed loop control algorithmbeing modified.
 3. The apparatus of claim 1, wherein the at least firstapplication programming interface is associated with one or moremedication delivery functions related to a medication delivery profile,a medication delivery profile modification, a safety shut off routine,operational status monitoring, and a data processing mode.
 4. Theapparatus of claim 1, wherein the control unit is further configured forcommunication with an analyte monitoring device comprising an analytesensor.
 5. The apparatus of claim 1, wherein the at least firstapplication programming interface is associated with one or more analytemonitoring functions related to a frequency of analyte data logging, adiagnosis of sensor operation, a failure mode related to the analytesensor, or an analyte sensor replacement schedule.
 6. The apparatus ofclaim 1, wherein the control unit is further configured forcommunication with a computer terminal through at least a secondapplication programming interface.
 7. The apparatus of claim 6, whereinthe control unit is further configured to receive the at least thirdclosed loop control algorithm through the at least second applicationinterface and store the at least third closed loop control algorithm inthe memory unit, wherein the stored at least third closed loop controlalgorithm forms a portion of the plurality of stored closed loop controlalgorithms.